NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required) | PA 19 092

Frequently Asked Questions (FAQs)

1) What is the NIH Exploratory/Developmental Research Grant Program (Parent R21) described here?

This opportunity is an NIH discretionary grant mechanism (R21) intended to help investigators launch early-stage, high-potential research ideas that are still exploratory or developmental. It is designed for projects where the main value is testing a new concept, generating preliminary evidence, or creating/refining a novel approach rather than completing a large, fully mature program of research.

2) What is the Funding Opportunity Number (FON) for this announcement?

The Funding Opportunity Number is PA 19-092.

3) What makes this Parent R21 announcement different from other R21 opportunities?

A defining feature of this specific Parent R21 is that it is for basic science experimental studies that involve human participants and that are considered clinical trials under NIH rules. In other words, it supports basic experimental research in humans that meets NIH's clinical trial definition, but the intent is foundational, mechanistic science rather than testing a practical product or intervention.

4) What kinds of projects is the R21 format meant to support?

The R21 format is meant for projects that are still in an exploratory or developmental stage. NIH frames these as potentially higher-risk studies that can open new directions, produce breakthroughs, or generate new tools, methods, models, or other innovations that significantly influence biomedical, behavioral, or clinical research.

5) Does this opportunity require studies with human participants?

Yes. This announcement is specifically intended for basic experimental studies that involve human participants.

6) Does this opportunity require that the study be considered a clinical trial under NIH rules?

Yes. The announcement is explicitly for basic experimental studies with humans that are considered clinical trials under NIH rules.

7) What does NIH mean here by a "clinical trial" in a basic science context?

In practical terms, NIH’s clinical trial definition applies because the study prospectively assigns people to one or more conditions and measures biomedical or behavioral outcomes. That prospective assignment can include actively manipulating an independent variable (for example, changing a task condition, presenting different stimuli, altering an experimental context, or assigning participants to different behavioral or physiological conditions) and then measuring outcomes in humans.

8) If it is a clinical trial, does that mean it is testing a treatment or intervention?

Not necessarily. Under this FOA, the purpose is basic research: understanding fundamental mechanisms or phenomena. The study may meet the clinical trial definition because of prospective assignment and outcome measurement, but it is not necessarily designed to test a product or intervention for a specific practical or clinical application.

9) What is the key distinction NIH uses to decide whether a project fits this FOA?

The distinction is intent. If the work is designed primarily to understand basic principles in humans without a specific downstream process or product in mind, it fits this FOA. If the work is oriented toward a specific application (such as evaluating a therapeutic, preventive strategy, diagnostic approach, service delivery model, or another targeted product/process outcome), NIH expects applicants to use a different funding opportunity announcement labeled as Clinical Trials Required or Clinical Trial Optional, as appropriate.

10) Where does NIH describe what counts as a prospective basic science study involving human participants?

NIH points applicants to the framework described in NOT-OD-18-212 for what counts as a "prospective basic science study involving human participants."

11) What types of outcomes are measured in studies supported under this FOA?

The description indicates that studies measure biomedical or behavioral outcomes in humans after prospective assignment to one or more conditions.

12) Does the proposed project need to align with an NIH Institute or Center (IC)?

Yes. The proposed project must align with the scientific missions and interests of one or more participating NIH Institutes and Centers. This alignment is described as a key factor in whether an application is considered responsive and potentially fundable.

13) Why is NIH Institute/Center alignment so important?

NIH is made up of multiple Institutes and Centers, each with different disease areas and scientific portfolios. Applicants are expected to ensure that the topic and aims clearly map onto at least one IC’s priorities, and that alignment affects responsiveness and fundability.

14) What is the listed award ceiling for this opportunity?

The provided funding parameter lists an award ceiling of $200,000.

15) Which agency administers this opportunity?

The opportunity is administered by the National Institutes of Health (NIH).

16) Are there multiple Assistance Listing (CFDA) numbers associated with this opportunity?

Yes. The opportunity is associated with multiple CFDA numbers (now commonly referred to as Assistance Listings), reflecting that NIH uses this parent mechanism across many institutes and scientific areas.

17) Who is eligible to apply (in general terms)?

Eligibility is broad and includes many organization types across government, education, nonprofit, and for-profit sectors, as well as certain tribal and foreign entities, as described in the opportunity information.

18) Which U.S. government entities are eligible?

Eligible applicants include state governments, county governments, city or township governments, and special district governments.

19) Are schools and universities eligible?

Yes. Eligible applicants include independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education.

20) Are tribal governments and tribal organizations eligible?

Yes. Eligible applicants include federally recognized Native American tribal governments, and Native American tribal organizations that are not federally recognized tribal governments.

21) Are nonprofit organizations eligible?

Yes. The eligible applicants include nonprofits with or without 501(c)(3) status, as long as they are not institutions of higher education.

22) Are for-profit organizations eligible?

Yes. Eligible applicants include for-profit organizations other than small businesses, and small businesses.

23) Are faith-based or community-based organizations included as eligible?

Yes. The announcement explicitly calls out faith-based or community-based organizations among the categories NIH is encouraging or recognizing as eligible.

24) Are U.S. territories or possessions included?

Yes. U.S. territories or possessions are explicitly called out among recognized eligible categories.

25) Are non-U.S. entities (foreign organizations) eligible?

Yes. Non-U.S. entities (foreign organizations) are explicitly called out among recognized eligible categories.

26) Does the opportunity mention eligibility for specific types of minority-serving institutions?

Yes. It explicitly calls out Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

27) Are eligible federal agencies included?

Yes. Eligible federal agencies are explicitly called out among recognized eligible categories.

28) Is there an "other" eligibility category?

Yes. The eligibility list includes an "other" category that typically captures additional eligible organizational forms under NIH policy.

29) What is the original closing date shown in the provided data?

The original closing date shown is May 24, 2020.

30) When was the opportunity record created (based on the provided data)?

The opportunity record creation date is November 28, 2018.

31) How does NIH describe the overall purpose of this FOA?

Overall, this FOA is positioned as a structured way to obtain NIH support for early, conceptually driven experiments in humans that are basic science in intent, potentially high impact, and aligned with an NIH Institute or Center’s mission.

32) What types of scientific contributions does NIH suggest these projects can produce?

NIH highlights that these exploratory studies can open up new directions, produce breakthroughs, or yield innovations such as new tools, methods, models, or other advances that significantly influence biomedical, behavioral, or clinical research.